Telix Granted FDA Orphan Drug Designation for Bone Marrow Conditioning Treatment
Summary : Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States Food and Drug Administration (FDA) has…
Summary : Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States Food and Drug Administration (FDA) has…
Summary Taiwan Food and Drug Administration (TFDA) has accepted the New Drug Application/Orphan Drug Registration (NDA/ODR) for CAN108 (maralixibat oral solution (LIVMARLI TM))…
Synopsis : IQVIA announced an agreement today with argenx SE. The multi-year contract covers a unique collaboration for the development of new…
Summary : Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol…
Summary : The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending…
Summary : AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic…
Summary : Alembic Pharmaceuticals received a tentative approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug…
Summary : Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility. Sanofi has…
Summary : It’s an understatement to note that the bottom lines for Moderna and Pfizer have been fattened by the success of…
Summary : The U.S. Food and Drug Administration turned down Ocugen’s Emergency Use Authorization (EUA) request for Covaxin in children 2 to…